Data / Medical devices / United States / Private Label Productions, LLC
Private Label Productions, LLC: FDA-registered device maker in Bonita Springs, FL, United States, 2 510(k) clearances
Private Label Productions, LLC is registered with the FDA (registration 3016616658) in Bonita Springs, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 29, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016616658
- Address
- 28790 South Diesel Drive, Bonita Springs, FL, United States, 34135
- Owner or operator
- Private Label Productions, LLC (10087128)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 17, 2023
- Registered through
- 2026
- Brand names listed
- Personal Lubricant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 29, 2016 | K160763 | ally Liquid Personal Lubricant | NUC | Substantially Equivalent | Private Label Production, LLC | accessdata.fda.gov |
| June 14, 2016 | K160717 | ally Warming Liquid Personal Lubricant | NUC | Substantially Equivalent | Private Label Production, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 29, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.